OIL CONTROLLING MAKEUP SPF 15- octinoxate octisalate oxybenzone lotion 
JAFRA COSMETICS INTERNATIONAL

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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OIL CONTROLLING MAKEUP SPF-15

SUNSCREEN ACTIVE INGREDIENT (SPF 15):
OCTINOXATE/ETHYLHEXYL METHOXYCINNAMATE, OCTISALATE/ETHYLHEXYL SALICYLATE, OXYBENZONE/BENZOPHENONE-3

PURPOSE: SUNSCREEN

OTHER INGREDIENTS: WATER/AQUA, BUTYLENE GLYCOL, ISOPROPYL PALMITATE, ISOPROPYL ISOSTEARATE, POTASSIUM CETHYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, GLYCERYL STEARATE, DI-PPG-3 MYRISTYL ETHER ADIPATE, SILICA, STEARIC ACID, ZINC OXIDE/CI 77947, POLYSORBATE 20, LECITHIN, POLYSILICONE-11, LAURETH-12, CYCLOPENTASILOXANE, ACRYLATES/DIMETHICONE COPOLYMER, DMDM HYDANTOIN, TRIHYDROXYSTEARIN, MAGNESIUM ALUMINUM SILICATE, XANTHAN GUM, PANTHENOL, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, WITHANIA SOMNIFERIA (WINTER CHERRY) EXTRACT, VIGNA RADIATA (MUNG BEAN) EXTRACT, TOCOPHERYL ACETATE, HAMAMELIS VIRGINIA (WITCH HAZEL) EXTRACT, SYMPHYTUM OFFICINALIS LEAF EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, CUCUMIS SATIVAS (CUCUMBER) FRUIT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, ALTHAEA OFFICINALIS ROOT EXTRACT, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, FRAGRANCE/PARFUM, TRISODIUM EDTA, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE [MAY CONTAIN, +/-: IRON OXIDES/CI 77491/CI 77492/CI 77499, TITANIUM DIOXIDE/CI 77891]  [FRAGRANCE/PARFUM CONTAINS: LIMONENE, LINALOOL, BUTYLPHENYL METHYLPROPIONAL (LILIAL), CITRONELLOL]

AN OIL FREE, LIQUID MAKEUP THAT CONTROLS EXCESS OIL AND PROVIDES FLAWLESS COVERAGE WITHOUT SHINE.

SPF 15 PROTECTS AGAINST DAMAGING ULTRAVIOLET RAYS. MATTE FINISH. SHEER TO MEDIUM COVERAGE.

TO USE: SMOOTH ON WITH FINGERS OR SPONGE.

CAUTION: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

DISCONTINUE USE IF SIGNS OF IRRITATION OCCUR.

KEEP OUT OF REACH OF CHILDREN.

CLINICALLY, ALLERGY AND IRRITANCY TESTED.

JAFRA

OIL CONTROLLING MAKEUP SPF 15

30 ML / 1 FL OZ

Oil Control Make-Up Labeling (04-2012)

OIL CONTROLLING MAKEUP  SPF 15
octinoxate octisalate oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-046
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
LAURETH-12 (UNII: OAH19558U1)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PANTHENOL (UNII: WV9CM0O67Z)  
IPOMOEA MAURITIANA TUBER (UNII: K67Y2SGX79)  
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)  
MUNG BEAN (UNII: 1LIB31N73G)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
COMFREY LEAF (UNII: DG4F8T839X)  
CHAMOMILE (UNII: FGL3685T2X)  
CUCUMBER (UNII: YY7C30VXJT)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
TEA TREE OIL (UNII: VIF565UC2G)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-046-671 in 1 BOX
1NDC:68828-046-1130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/19/2012
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Revised: 4/2012
Document Id: 540c038c-5736-4ce9-a4d6-cda4623d1444
Set id: 63592ad9-283f-46bb-9837-b72a53159cbb
Version: 1
Effective Time: 20120427
 
JAFRA COSMETICS INTERNATIONAL